Recall Z-0135-2014 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a D
| Date | Nov 1, 2013 (initiated Aug 26, 2013) |
| Status | Terminated |
| Reason | Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. |
| Root cause | Process control |
| Action | Edwards sent an Urgent Field Safety Notice Product Recall letter dated August 26, 2013 to all affected customer, via Fed-Ex. The product is sold directly to hospitals and distributors. The distributors involved will communicate with their customers directly. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their entire inventory, quarantine and return the affected products. An acknowledgement form is included for completion to assist in the assessment of the inventory. For questions contact Edwards Customer Service at 800-424- |
| Quantity | 140 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123298 | FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING Edwards Lifesciences, LLC, Mar 15, 2013 |